ATAI
Live News • Jun 05
AtaiBeckley Spotlights Phase 3 Depression Program at June Investor Conferences AtaiBeckley plans to present at multiple investor conferences in June 2026, including events hosted by Jefferies, Oppenheimer, HCW and UBS.
Management will focus on the Phase 3 pivotal ReConnection program for BPL-003, an intranasal 5-MeO-DMT candidate aimed at treatment-resistant depression.
Jefferies reiterated a Buy rating and a US$10 price target, highlighting BPL-003 and upcoming Phase IIb data for VLS-01, an oral DMT buccal film, as key clinical catalysts.
The concentration of June conference appearances indicates that the company is prioritizing visibility around its late-stage pipeline, especially the newly launched Phase 3 BPL-003 program.
Investors may wish to monitor any additional detail on study design, timelines and regulatory interactions for BPL-003 and VLS-01, as clinical progress and data readouts could be important influences on sentiment toward the stock. Major Estimate Revision • May 20
Consensus revenue estimates increase by 104% The consensus outlook for revenues in fiscal year 2026 has improved. 2026 revenue forecast increased from US$510.0k to US$1.04m. Forecast losses expected to reduce from -US$0.481 to -US$0.431 per share. Pharmaceuticals industry in the US expected to see average net income decline 13% next year. Consensus price target of US$14.00 unchanged from last update. Share price fell 4.6% to US$3.96 over the past week. Announcement • Apr 24
AtaiBeckley Inc. Announces Additional Phase 2A Results for EMP-01 Oral R-M Showing Large and Consistent Improvements in Social Anxiety Disorder AtaiBeckley Inc. announced expanded Phase 2a results for EMP-01 (oral R-MDMA) in adults with Social Anxiety Disorder (SAD) (n=70), demonstrating clinically meaningful and consistent improvements across clinician-rated symptoms, patient-reported experience, and real-world behavioral outcomes. At Day 43, EMP-01 achieved a 38% reduction vs 15% on placebo (Hedges’ g=0.84) on the patient-reported Social Phobia Inventory (SPIN), a 32% reduction vs 14% on placebo on the Subtle Avoidance Frequency Examination (SAFE), and a previously reported -11.9-point LS mean difference (LSMD) on the Liebowitz Social Anxiety Scale (LSAS) versus placebo (g=0.45), with 49% responder rates on both Clinical Global Impression-Improvement (CGI-I) (previously reported) and Patient Global Impressions of Change (PGI-C). EMP-01 was well tolerated, with no severe or serious adverse events. EMP-01 produced consistent and clinically meaningful improvements across all major symptom domains of SAD: LSAS: EMP-01 demonstrated a clinically meaningful LSMD of -11.9-points vs placebo (g=0.45) at Day 43 (previously reported), with both total and subscale improvements. Improvements were observed across both fear and avoidance subscales on the clinician-rated 24-item Liebowitz Social Anxiety Scale, indicating that patients experienced fewer social situations as distressing and were more able to engage in them. This degree of change is considered clinically meaningful and reflects broad symptom improvement across core features of social anxiety disorder including fear and anxiety of social situations. SPIN: EMP-01 produced a large, clinically meaningful patient-reported improvement of -18.3-points (38% reduction vs 15% on placebo), which corresponded to a large between-group standardized effect size (g=0.84), in self-reported SAD symptoms from baseline to Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -11.5 points (95% CI: -18.5, -4.6; p=0.002) at Day 43. Patients treated with EMP-01 moved from severe baseline symptom severity to substantially lower symptom burden by Day 43. These results on the 17-item SPIN are equivalent to being able to initiate conversations, attend social events, and perform at work with substantially less fear and avoidance. SAFE: EMP-01 demonstrated a large, clinically meaningful improvement of -25.9-points (32% reduction vs 14% on placebo) in real-world behavioral avoidance at Day 43. Additional model-based analyses further supported treatment benefits at Day 43, showing statistically significant improvements with a placebo-adjusted LSMD of -15.6 points at Day 43 (95% CI: -26.0, -5.2; p=0.004). These results on the Subtle Avoidance Frequency Examination, a 32-item questionnaire that measures safety behaviors, suggest that participants were more willing to participate in everyday activities such as social interactions without engaging in avoidant coping behaviors. Clinical impression: 49% CGI-I responders (NNT=2.95) at Day 43 compared to 15% on placebo (previously reported). This measure reflects clinicians’ overall judgment of meaningful improvement in a patient’s condition, considering symptom severity, functioning, and overall clinical presentation. Patient perception: 49% PGI-C responders (NNT=2.72) at Day 43 compared to 12% on placebo. This result indicates that patients themselves perceived the treatment-associated improvements as noticeable and meaningful in their daily lives, reinforcing the clinical and functional outcomes observed on other measures. Safety & Tolerability: EMP-01 was generally safe and well tolerated: No SAEs and no severe TEAEs in any participant; 97% retention, with 0% study dropouts attributed to TEAEs; TEAEs were expected and consistent with the class, transient, and predominantly mild-to-moderate. The multi-center study enrolled 71 adults with moderate-to-severe SAD across 7 clinical sites in the UK. Participants were randomized to receive two in-clinic administrations of EMP-01 (225 mg) or placebo, given 28 days apart, with no adjunctive psychotherapy. 70 participants received at least one dose of study drug, and 69 completed the Day 43 efficacy assessments, indicating high patient acceptability and retention. All clinician-rated assessments were conducted by blinded central raters. 
